Alvotech Nears Inflection Point With 5 U.S. Biosimilars Targeted by Year-End

Key Points

• Alvotech says it is at an “inflection point,” with management expecting five U.S. biosimilars on the market by year-end after recent FDA resubmissions. The company currently has two U.S. products and is aiming to launch biosimilars to Simponi Aria, Eylea and Prolia/Xgeva.
• The company is working through FDA remediation after prior complete response letters, saying it has completed more than 200 CAPAs and passed multiple inspections. Management said the FDA review clock for the latest resubmissions should be six months, and another inspection may or may not be needed.
• Alvotech is also expanding its manufacturing capacity through a partnership with Fujifilm, which is expected to begin supplying products after mid-2026. The company is simultaneously advancing a broader pipeline, including Entyvio and high-dose Eylea biosimilars, while guiding for 2026 revenue of $650 million to $700 million.

Alvotech NASDAQ: ALVO is at an “inflection point” after more than a decade of investment in its biosimilar platform, Founder and Executive Chairman Róbert Wessman said at the Jefferies Global Healthcare Conference in New York.

Speaking with Jefferies analyst Marco Baruzzi, Wessman said Alvotech has invested about $2 billion in the business since its founding in 2013, including a significant amount in its product portfolio. He described the company as a fully integrated biosimilar platform, with in-house research and development, manufacturing, regulatory and device assembly capabilities.

Wessman said Alvotech currently has five products on the market outside the United States and two products on the market in the U.S. He said the company expects to have five products on the U.S. market by the end of this year, following recent regulatory resubmissions.

FDA Resubmissions and CRL Remediation

Alvotech recently resubmitted U.S. biologics license applications for biosimilars to Simponi Aria and Eylea, Wessman said. He described the Simponi Aria biosimilar as particularly important, noting that Alvotech was first to launch the product in Europe and that its marketing partner is gaining market share in several key European markets.

Wessman said Alvotech believes it remains in the “first wave” for the U.S. market and sees limited competition, with only one known filer. He said the company assumes it will launch three products in the U.S. by the end of the year: biosimilars to Simponi Aria, Eylea and Prolia/Xgeva.

Asked why Prolia was not included in the recent resubmission announcement, Wessman said the company’s partner holds the U.S. marketing authorization and is responsible for that filing. He said that resubmission is “imminent” and could occur within days.

Wessman also addressed prior complete response letters from the FDA, saying the company has strengthened processes related to manufacturing and customer complaints. He said Alvotech has implemented more than 200 corrective and preventive actions, or CAPAs, and completed multiple FDA inspections since entering the U.S. market in mid-2024.

He said the company’s Iceland facility had a routine good manufacturing practice inspection that concluded in May. Following the resubmission, Wessman said the FDA review clock is expected to run for six months, and the agency may either conduct another inspection or rely on the recent inspection. “The company, the facility, and the team is fully ready to receive FDA whenever they want to come,” he said.

Fujifilm Partnership Adds Manufacturing Capacity

Wessman said Alvotech’s recently announced partnership with Fujifilm expands its global manufacturing network and provides additional commercial supply capacity in the U.S. and U.K.

He said the company began preparing more than two years ago for potential regulatory changes that could reduce the need for certain clinical studies in biosimilar development. That led Alvotech to increase capacity in cell line development, process development and scale-up work.

Wessman said the Fujifilm relationship is intended to support both existing commercial products and pipeline assets, with supply expected to begin after mid-2026. He said the added capacity is important because Alvotech expects multiple products to move through the commercial funnel at the same time.

Pipeline Focus: Entyvio, Eylea and Launch Cadence

Alvotech has submitted a marketing authorization application to the European Medicines Agency for a biosimilar to Entyvio. Wessman said Entyvio was a relatively small product when Alvotech began development, but global brand sales have since grown to about $7.5 billion.

He said Alvotech believes it is in “pole position” and could be first to market with an Entyvio biosimilar. He also said the company expects to complete global submissions, including in the U.S., this year.

Wessman also highlighted Alvotech’s work on a high-dose biosimilar to Eylea. He said Alvotech began developing a high-dose formulation after anticipating that the brand would move from a 2-milligram version to an 8-milligram version. According to Wessman, one of Alvotech’s formulations matched Regeneron’s high-dose Eylea product.

He said development for markets outside the U.S. is essentially complete and that Alvotech has started clinical work because the FDA did not provide a clinical waiver.

Biosimilar Market Outlook and 2026 Guidance

Wessman described the broader biosimilar market as a major long-term opportunity, saying biologics represent about 40% of the $1.8 trillion pharmaceutical market and could grow to 50% to 60% over time. He said biosimilars are needed to expand access and reduce healthcare costs for chronic-use biologic medicines.

He said Alvotech selects pipeline candidates based on whether the product can add value by opening access and whether the company believes it can be first to market or in the first wave of competition. He said the company now has about 30 products in its pipeline.

On potential FDA changes to biosimilar development requirements, Wessman said he does not view the barrier as being reduced, but rather that some patient studies may be replaced by other methods of demonstrating biosimilarity. He said biosimilar development may still cost $60 million to $100 million per product and take about five to six years.

Discussing 2026 guidance, Wessman said Alvotech has guided for revenue of $650 million to $700 million and EBITDA of $180 million to $220 million. He said the high end includes a small amount of U.S. launch revenue at the end of this year, while the range also reflects a downside scenario in case of further delays, which he said the company does not currently assume.

Balaji Prasad, Alvotech’s Chief Scientific Officer, also spoke briefly in response to an audience question. Prasad said he followed Alvotech after its Nasdaq listing in 2022 and viewed the company as one of the best-positioned players in biosimilars before joining. He said he was drawn to the company’s mission of expanding access to lower-cost, high-quality biosimilars worldwide.

About Alvotech NASDAQ: ALVO

Alvotech NASDAQ: ALVO is a global biopharmaceutical company specializing in the development, manufacturing and commercialization of biosimilar medicines. The company focuses on creating high‐quality, cost‐effective alternatives to established biologic therapies in areas such as immunology, oncology and other specialty care fields. By leveraging in‐house research and a vertically integrated manufacturing platform, Alvotech aims to bring approved biosimilars to market more rapidly and with greater cost efficiency than many traditional biosimilar developers.

Since its founding in 2013, Alvotech has built a diversified pipeline of monoclonal antibody biosimilars, targeting blockbuster reference products including adalimumab (originally branded Humira), bevacizumab (Avastin) and ustekinumab (Stelara).

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